News

What The Washington Post Won’t Say About Distributors and Regulation of Controlled Substances in the Supply Chain

October 15, 2017

The recent investigation by The Washington Post presented a misleading picture about the role of healthcare distributors in the pharmaceutical supply chain and the regulation of controlled substances and opioids in the market. Here are the facts and the information that The Post won’t share about the industry’s role and our members’ efforts to prevent diversion of controlled substances across the healthcare system.

Fact: There is broad recognition among leading public health authorities that opioids have been overprescribed — a trend that began in the 1990s and continues to this day.

Further, research points to high rates of misuse and diversion taking place after a prescription is dispensed. A 2013 study by the Department of Health and Human Services (HHS) found that the vast majority of prescription drug diversion occurs after pharmacies fill prescriptions. More than two-thirds of non-medical users obtained the prescription drug from a friend or family member.

Distributors have no access to patient information, nor are they qualified to question a licensed physician’s recommended treatment plan for their patient, including prescriptions. A main tool to prevent abuse of prescription drugs is the prescription itself. The CDC recently released updated, evidence-based guidelines on prescribing opioids for chronic pain. This was a critical step to ensure safe and medically appropriate treatment plans for patients, and HDA is encouraged by recent reporting that doctors are beginning to change the way they approach pain management and the use of narcotic pain pills.

Fact: Distributors DO NOT manufacture opioids, license registrants, write prescriptions or dispense medicines. The Drug Enforcement Administration (DEA) is responsible for setting the amount of opioid drugs that can be produced and sold in the U.S. every year.

Pharmaceutical distributors have no mechanism to increase demand or patients’ use of opioids. Our primary role is to coordinate the logistics for the safe and secure distribution of all medications, including controlled substances, from drug manufacturers to DEA-licensed pharmacies and other healthcare providers. This fact is often ignored by The Washington Post.

Assessing the demand and supply of opioids is the responsibility of the DEA, which licenses the entities who are prescribing, distributing and dispensing the medicines. Further, the DEA sets the annual production quotas for opioids based on “legitimate medical need” and determines the amount of opioids that can be manufactured each year. From 2004 to 2013, the DEA increased production of controlled substances, effectively adding to the supply of opioids on the market. For example, the DEA approved increased production of oxycodone during this time by more than 200 percent.

Fact: The DEA is also the only entity to know the full scope of opioids that are being distributed and dispensed across the country at any given time.

While distributors must report each controlled substance order that is filled and those that are deemed suspicious to the DEA, a distributor only knows what it ships to a particular dispenser. The DEA is the only entity that has a window — via its own ARCOS database — into the entire shipment and handling of controlled substances in the market. Further, the DEA is supposed to provide that “full picture” perspective of the supply chain to registrants, and yet failed to do in the past.

Fact: While effective communication and collaboration among the DEA and registrants remains critical to identifying abuse and diversion in real-time, the response from the DEA during the height of the epidemic was limited.

Prior to congressional action, communication between the DEA, which serves as the primary regulator for controlled substances, and DEA registrants certified to handle controlled substances (including distributors, pharmacists and doctors) was virtually non-existent. Despite many requests for clarity, the DEA too often did not help pharmacies, doctors and distributors understand exactly how the DEA wanted them to operate and what information the DEA wanted them to report.

Despite this lack of guidance, distributors regularly report suspicious activity to the DEA and — when appropriate — cut off the supply of products to customers when “red flags” of possible drug diversion or other illegal activity are observed. From across the industry, wholesalers have sent tens of thousands of suspicious order reports to the agency.

The GAO in a June 2015 report concluded that, “DEA communication with and guidance for its registrants are essential to help ensure that registrants take actions that prevent abuse and diversion but do not unnecessarily diminish patients’ access to controlled substances for legitimate use because of their uncertainty about how to appropriately meet their [Controlled Substances Act (CSA)] roles and responsibilities.”

Targeted, rapid response against opioid abuse and diversion is a challenge and requires a positive relationship between distributors and the DEA. The DEA can assist distributors in their efforts by responding to compliance questions around patient safety monitoring and enforcement. In addition, by sharing data and information there will be additional opportunities to identify and curb misuse, overuse and abuse of prescription opioids.

In 2016, Congress enacted the Ensuring Patient Access and Effective Drug Enforcement Act (S. 483/Public Law 114-145) — without dissent — marking a dramatic change in information sharing and collaboration among distributors, other registrants, and the DEA. This law does not “decrease” the DEA’s enforcement against distributors; it supports real-time communication between all parties in order to counter the constantly evolving methods of drug diversion. Specifically:

The DEA remains fully empowered to take quick action against a DEA registrant (i.e., prescribing physician, pharmacist, distributor, manufacturer) if there is “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur….”

In circumstances where there is a lack of regulatory clarity around a DEA registrant’s roles and responsibilities, a corrective action plan provides a registrant 30 days to adequately address the DEA’s concerns.

Fact: Distributors are strongly COMMITTED to finding systemic solutions to the challenges that contributed to the opioid epidemic.

Distributors are strongly committed to addressing the challenges that contributed to the opioid epidemic, including efforts to improve provider and patient education around the risks associated with abuse; increase awareness of new clinical prescribing guidelines and recommendations; and enhance efforts to reduce and dispose of unnecessary medications.

Distributors stand ready to work with all players across the system — physicians, pharmacists, manufacturers, federal and state regulators, law enforcement, and others — to identify and stop rogue actors who intentionally undermine patient safety and the public health.

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.